MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0701-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the available information the cause of death cannot be determined.Additionally, death is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
This report is being conservatively filed due to a patient death, unknown if device related.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) grade 4+.One mitraclip was implanted, reducing the mr to grade 2+.There was no device deficiency.On (b)(6) 2023, the patient passed away due to an unknown cause.Reportedly, additional details were not available at this time.There was no device malfunction noted.No additional information was provided regarding this issue.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16644294
• Report Number: 2135147-2023-01400
• Device Sequence Number: 6157618
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10419R153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG